Effect of Erythropoietin on the Incidence of Acute Kidney Injury Following Complex Valvular Heart Surgery

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01758861
• Other study ID #: 4-2011-0355
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2012
• Last updated: December 31, 2012
• Start date: July 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Acute kidney injury (AKI) frequently occurs after cardiac surgery using cardiopulmonary bypass (CPB). Recombinant human erythropoietin (rHuEPO) is known to provide organ protection against ischemia-reperfusion injury through its anti-inflammatory properties. The aim of the present study was to investigate the effect of a single preoperative bolus of EPO on the incidence of AKI following complex valvular heart surgery in a randomized, controlled and double-blind trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• preoperative risk factors for AKI and scheduled for complex valvular heart operations

• Enrolled criteria for high risk of AKI were patients with more than 2 of bellows:

female, serum creatinine >1.2 mg/dl, preoperative A-fib, GFR < 60 ml/min, NYHA class IV, HTN, DM, age > 65 years, peripheral vascular disease.

• Complex valvular heart operations were defined as double-valve surgery, combined valve and coronary artery bypass grafting procedures, Bentall operation, combined mitral valve surgery and tricuspid annuloplasty or reoperation.

Exclusion Criteria:

• Patients with preexisting uncontrolled hypertension (diastolic blood pressure > 100 mmHg), immunosuppression, history of thromboembolism, malignant disease, seizure, liver dysfunction, renal impairment (serum creatinine > 2 mg/dL), and drug or alcohol abuse were excluded.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• EPO group

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Department of anesthesiology and pain medicine Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute kidney injury	The diagnostic criteria for AKI is followed by AKIN criteria (absolutely increase in the SCr concentration = 0.3 mg/dL from baseline, = 50% increase in the SCr concentration within 48 hours after operation).	change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5	No